Analysis and comparison of the review document submitted by Pfizer to the US Food and Drug Administration, on the basis of which the FDA gave the green light to expand the emergency permit for vaccination also for children aged 12-15 (1), as opposed to the study protocol in children (2, 3), reveal concerning findings, including violations of the protocol established by Pfizer itself, and no less serious, designing the trial protocol in a way that will allow the company to present as positive findings as possible in terms of vaccine safety in children.
Violation of protocol conditions – How did children with a psychiatric diagnosis get to be included in the study?
According to the review document submitted by Pfizer to the FDA, four of the 1,131 children in the study arm who received Pfizer-BioNTech COVID-19 Vaccine suffered from serious adverse events (“SAEs”) – that is, events in which at least one criterion was met: caused death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, or congenital anomaly/birth defect.
Of these four children, three had such severe depression that they were hospitalized shortly after vaccination (in the first 7 days after the first dose, in the second only one day after the second dose, and in the third 15 days after the first dose, respectively).
The consequence of this finding is extremely worrying, as it means that one in every 350-400 children who are vaccinated might suffer from severe depression and need hospitalization.
To reassure us, Pfizer notes in its review document that in fact, all three children had a pre-existing diagnosis of anxiety and depression. Moreover, they explain – all three actually reported a selective serotonin reuptake inhibitor (SSRI) that began within 1-2 months prior to vaccination.
“Worsening suicidal ideas with initial SSRI treatment in adolescents”, they explain, “is a recognized risk and provides a reasonable alternative explanation for depression exacerbation in these BNT162b2 recipients”. So here you go – why blame the vaccine, when there is a perfectly reasonable and logical alternative explanation for the exacerbation of their depression?
What is the problem with this explanation?
Two problems:
- The claim that the SSRIs the children received is an alternative explanation for the deterioration of the children’s mental state is doubtful. According to the scientific literature, exacerbation of suicide and mental state occurs right at the beginning of treatment with antidepressants, usually in the first two weeks, and certainly not more than a month after starting treatment – which is the time when you start to see improvement. In fact, the opposite is true: if there is no improvement within four weeks, a medication is usually replace
